MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASON

Model Number 989605410251

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

The customer reported that the articulating arm is unable to be locked on their affiniti 50 ultrasound system.It is unknown at this time if the system was mobile when failure occurred.There is no death or serious injury was reported.Philips has made multiple attempts to contact the customer for further information to no avail.If further information becomes available a supplemental report will be submitted.

• Brand Name: AFFINITI 50
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASON
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16397918
• MDR Text Key: 309862294
• Report Number: 3019216-2023-00018
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605410251
• Device Catalogue Number: 795208
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1